Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 878.4630 - Ultraviolet lamp for dermatologic disorders.

(a) Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360l,371
source: 53 FR 23872, June 24, 1988, unless otherwise noted.
cite as: 21 CFR 878.4630